ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000440022

Ethics application status

Approved

Date submitted

20/05/2010

Date registered

1/06/2010

Date last updated

12/07/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

CLEMENT Capecitabine-radiosensitizing Lutetium-177 octreotate endoradiotherapy management of endocrine neurogenic tumours

Response and Toxicity Assessment

Scientific title

CLEMENT Capecitabine-radiosensitizing Lutetium-177 octreotate endoradiotherapy management of endocrine neurogenic tumours

Response and Toxicity Assessment

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

CLEMENT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Neuroendocrine tumour

Neuroendocrine malignancy

Condition category

Condition code

Cancer

Neuroendocrine tumour (NET)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a single arm study and all patients receive the same combination regimen as follows: Lutetium -177 octreotate radiopeptide therapy with radiosensitizing chemotherapy. Capecitabine/temozolomide
Lutetium-177 octreotate: 4 cycles at 8 week intervals
7.8 GBq per cycle intravenously on day 1
Capecitabine 1650 mg per metre squared daily for 14 days each 8 weeks for 4 cycles, oral formulation
Temozolomide 200 mg per metre squared once daily for 5 days each 8 weeks for 4 cycles, oral formulation. Every patients receives a standard amino acid solution and standard anti-nausea treatment.

Intervention code [1]

Treatment: Other

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

No standard treatment of NET exists
Outcomes will be compared to those reported in the published literature for example the recent South Australian Review of Neuroendocrine Tumour Treatment.
The single centre seminal study of Lutetium-177 octreotate radiopeptide therapy of NET as a single agent from the Erasmus Medical Centre, Rotterdam, The Netherlands reported by: Kwekkeboom et al. will be used as the definitive historical comparator since we use the same activity of the same radiopharmaceutical over the same number of cycles in patients with the same eligibility criteria.
Kwekkeboom DJ, de Herder WW, Kam BL et al. Treatment with the radiolabeled somatostatin analog [177 Lu-DOTA 0, Tyr 3] Octreotate: Toxicity, Efficacy and Survival. J Clin Oncol 26:2124-2130, 2008

Control group

Historical

Outcomes

Primary outcome [1]

progression-free survival
measurement of target lesions on computer tomography, magnetic resonance imaging (CT/MRI) using standard Response Evaluation in Solid Tumours (RECIST) criteria version 1.1 2009

Timepoint [1]

objective response rate evaluation at 1 year from commencement of therapy

Primary outcome [2]

Progression-free survival measurement of target lesions on CT/MRI using standard RECIST criteria version 1.1 2009

Timepoint [2]

Actuarial survival 1,2,3 years from commencement of treatment.

Secondary outcome [1]

overall survival as determined by direct individual patient follow-up by the Investigators

Timepoint [1]

actuarial survival 1, 2 3 years from commencement of treatment

Secondary outcome [2]

toxicity is assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3 (CTCAE)

Timepoint [2]

3 years from commencement of treatment. Myelotoxicity fortnightly for 2 months.Nephrotoxicity 6 monthly for 3 years.

Eligibility

Key inclusion criteria

progressive disseminated unresectable well-differentiated neuroendocrine tumours

Minimum age

18 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

impaired renal function, poor performance status, poorly differentiated tumours, inadequate cardiac and hepatic function, impaired haemopoetic reserve platelets less than 100 neutrophils less than 1.5. Chemotherapy within 2 months. Residence outside Western Australia.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

referral by patient's oncologist to the principal investigators

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

physician-sponsored study

Phase

Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

26/07/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6160

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Government of WA Cancer Network

Address [1]

Department of Oncology and Nuclear Medicine, Fremantle Hospital, Alma Street, Fremantle WA 6160

Country [1]

Australia

Primary sponsor type

Hospital

Name

Fremantle Hospital Health Service

Address

Fremantle Hospital, Alma Street, Fremantle WA 6160

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committe South Metropolitan Area Health Service

Ethics committee address [1]

Fremantle Hospital
Alma Street, Fremantle WA 6160

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/01/2006

Approval date [1]

17/05/2006

Ethics approval number [1]

1/06/0201

Ethics committee name [2]

Human Research Ethics Committee, South Metropolitan Area Health Serivce

Ethics committee address [2]

Fremantle Hospital
Alma Street, Fremantle WA 6160

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

19/01/2009

Approval date [2]

27/02/2009

Ethics approval number [2]

9/01/2010

Summary

Brief summary

177Lu-Octreotate is synthesized from [DOTA,Tyr3]Octreotate labelled with 177LuCl3 (7.8 GBq) distributed by IBD (Baarle-Nassau, the Netherlands). Each patient receives an infusion of aminoacids (Baxter Synthamin) containing 11.6g lysine and 23g arginine/L at 250 ml/hr. Thirty minutes later the radiolabelled somatostatin analogue is co-infused via a side-line over 10-20 minutes. Routine antiemetic therapy is given in the form of Tropisetron (5mg) intravenous (IV) bolus and oral Lorazepam (2mg).  The chemotherapy with oral Capecitabine 1650mg/m2 will be reduced to 1500mg/m2 (in line with the American Society of Clinical Oncology (ASCO) dosage), for 14 consecutive days, and commenced on the morning of radionuclide therapy. Cycles will repeated each 8 weeks at the time of each subsequent radionuclide infusion. Temozolomide will be introduced on a dose escalation schedule, in cohorts of 3 patients, commencing at 100mg/m2 for 5 days. A standard dose escalation trial design will be followed with 3 patients completing 2 cycles at the starting dose (100mg/m2) prior to escalation to 150mg/m2 in the next 3 patient cohort. The ultimate maximum dose will not exceed the 200mg/m2 safe level established in the ASCO protocol. In the absence of toxicity all subsequent patients will be treated at this level
All of the previously monitoring, including weekly blood testing and 2 monthly scanning, will remain unchanged from the original CLEMENT protocol.

Assessments: Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) will be performed at baseline and then at each new treatment cycle (8 weeks). Quantitative uptake of 177Lu-octreotate in the tumours will be measured by serial whole body imaging at 4, 24, 48 hours   and 5 days and graded according to a 4 point visual scale.

Trial website

Trial related presentations / publications

Phillip G. Claringbold , Paul A. Brayshaw ,  Richard A. Price , J. Harvey Turner. Phase II study of radiopeptide Lutetium-177-octreotate and Capecitabine therapy of progressive disseminated neuroendocrine tumours. Eur J Nucl Med Mol Imaging, under review

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Ms. Jenny Lavin

Address

Department of Nuclear Medicine
Fremantle Hospital
Alma Street
Fremantle WA 6160

Country

Australia

Phone

61 08 9431 2888

Fax

61 08 9431 2889

Jenny.Lavin@health.wa.gov.au

Contact person for scientific queries

Name

Professor J. Harvey Turner

Address

Department of Nuclear Medicine
Fremantle Hospital
Alma Street
Fremantle WA 6160

Country

Australia

Phone

61 08 9431 2888

Fax

61 08 9431 2889

Harvey.Turner@health.wa.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Pancreatic neuroendocrine tumor control: Durable objective response to combination 177Lu-octreotate-capecitabine-temozolomide radiopeptide chemotherapy.	2016	https://dx.doi.org/10.1159/000434723
Embase	Theranostic Outcomes in Clinical Practice of Oncology: What, so What, Now What? What's More.	2019	https://dx.doi.org/10.1089/cbr.2019.29006.jht

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically